Label: PROVITA HOOFSURE ENDURANCE XL- formic acid solution, concentrate

  • NDC Code(s): 16371-106-01, 16371-106-02, 16371-106-03, 16371-106-04, view more
    16371-106-05, 16371-106-07
  • Packager: Provita Eurotech Ltd
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 11, 2018

If you are a consumer or patient please visit this version.

  • VETERINARY INDICATIONS

    Hoofsure Endurance is a scientifically proven proprietary blend of organic acids, essential oils and wetting agents specifically designed and formulated to both clean and care for hooves. It is safe, non-toxic, biodegradable and does not contain copper, formaldehyde or antibiotics.

    Hoofsure Endurance is intended for use as part of a hoof maintenance program in conjunction with your veterinarian. Hoof health is dependent on good nutrition, hygiene, management and herd health care. Footbathing is a control measure and not a treatment. To optimize hoof health, a treat and control protocol is recommended. Lame cows should be identified, footbathed regularly and treated with an appropriate product such as Provita Konquest gel and Provita Combat spray.

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  • Ingredients

    Organic Acids (Acetic and Formic), Water, Ethanol, Alkoxylated Cetyl Alcohol, Laureth-4, Tea-tree Oil, E124, E133

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  • Disposal

    Hoofsure Endurance is environmentally friendly. After use, spent footbath can be disposed of by landfill or flushing to a slurry lagoon in accordance with local regulations.

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  • Precautions

    Do not use in galvanised footbaths.

    Care must be taken when handling undiluted product.

    Wear suitable protective clothing and eye protection.

    Do not breathe vapour.

    Contains Formic Acid.

    Causes burns.

    In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

    Keep out of reach of children.

    See Health and Safety Data Sheet.

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  • Directions for Use

    DAIRY CATTLE For footbath use: For optimum results footbath at every milking, every day. Mix Hoofsure Endurance 1:100 (equivalent to a 1% solution - e.g. half gallon of Hoofsure Endurance with 50 gal clean water in a 50 gal footbath). When required, a 2% or above dilution rate may be used. Place footbath in return alley, not in parlor. Wash dirt and manure off feet prior to walking through the footbath. Ideally, use a pre-wash bath.

    Number of cow passes before filling fresh footbath (approximate):
    Footbath Capacity Number of Cow Passes*
    *
    Ensure footbath solution is at 5" depth or above at all times. Check depth of solution every 200 cows and top up, as necessary, using a top up solution (mix ½ gallon of Hoofsure Endurance with 5 gallons of water and add to the footbath. Use of heavily soiled footbaths can become a source of infection or re-infection.
    25 gals up to 250
    50 gals up to 500
    100 gals up to 1000

    For topical application: After inspection or trimming, administer a 25% solution of Hoofsure Endurance (i.e. 4 oz Provita Hoofsure Endurance mixed with 20 oz of clean water). Using a sprayer, apply to the hoof once per day for up to 3 weeks.

    BEEF CATTLE For footbath use: Footbath every 4-6 weeks. Mix Hoofsure Endurance 5:100 (equivalent to a 5% solution - e.g. 5 gallons of Hoofsure Endurance with 100 gal clean water in a 100 gal footbath). Wash dirt and manure off feet prior to walking through the footbath. A 100 gal footbath can have 1000 cow passes before needing filled fresh.

    *Ensure footbath solution is at 5" depth or above at all times. Check depth of solution every 200 cows and top up, as necessary, using a top up solution (mix ½ gallon of Hoofsure Endurance with 5 gallons of water and add to the footbath. Use of heavily soiled footbaths can become a source of infection or re-infection.

    For topical application: After inspection or trimming, administer a 25% solution of Hoofsure Endurance (i.e. 4 oz Provita Hoofsure Endurance mixed with 20 oz of clean water). Using a sprayer, apply to the hoof.

    SHEEP For footbath use: Footbath every 2-4 weeks. Mix Hoofsure Endurance 1:100 (equivalent to a 1% solution - e.g. half gallon of Hoofsure Endurance with 50 gal clean water in a 50 gal footbath). When required, a 2% dilution rate may be used. Walk sheep through footbath 3 times or allow sheep to stand in the solution for a short period. A 50 gal footbath can have up to 1000 sheep passes before needing filled fresh.

    Number of sheep passes before filling fresh footbath (approximate):
    Footbath Capacity Number of Sheep Passes*
    *
    Ensure footbath solution is at 3" depth or above at all times. Check depth of solution every 100 sheep and top up, as necessary, using a top up solution (mix ½ gallon of Hoofsure Endurance with 5 gallons of water and add to the footbath).
    25 gal up to 500
    50 gal up to 1000

    For topical application: After inspection or trimming, administer a 25% solution of Hoofsure Endurance (i.e. 4 oz Provita Hoofsure Endurance mixed with 20 oz of clean water). Using sprayer, apply to the hoof.

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  • SPL UNCLASSIFIED SECTION

    1.25gal
    (4.75 Litres)

    Provita Eurotech Limited,
    21 Bankmore Road, Omagh, Co. Tyrone,
    Northern Ireland, BT79 0EU
    Provita Animal Health LLC
    4500 140TH Avenue North, Suite 101
    Clearwater, FL 33762
    Tel: + (1) 727 431 9511
    Email: info@provita-animalhealth.com

    www.provita-animalhealth.com

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  • PRINCIPAL DISPLAY PANEL - 992 Litre Drum Label

    Provita
    Animal Health Naturally

    NEW

    Hoofsure
    Endurance XL

    A footbath solution for healthy hooves
    and to aid in the control of footrot

    Makes
    26,200
    Gallons

    PRINCIPAL DISPLAY PANEL - 992 Litre Drum Label
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  • INGREDIENTS AND APPEARANCE
    PROVITA HOOFSURE ENDURANCE XL 
    formic acid solution, concentrate
    Product Information
    Product Type OTC ANIMAL DRUG Item Code (Source) NDC:16371-106
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FORMIC ACID (UNII: 0YIW783RG1) (FORMIC ACID - UNII:0YIW783RG1) FORMIC ACID 608 g  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LAURETH-4 (UNII: 6HQ855798J)  
    Product Characteristics
    Color BLUE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:16371-106-01 4.75 L in 1 DRUM
    2 NDC:16371-106-02 19 L in 1 DRUM
    3 NDC:16371-106-03 57 L in 1 DRUM
    4 NDC:16371-106-04 114 L in 1 DRUM
    5 NDC:16371-106-05 209 L in 1 DRUM
    6 NDC:16371-106-07 992 L in 1 DRUM
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 01/04/2004
    Labeler - Provita Eurotech Ltd (238318232)
    Establishment
    Name Address ID/FEI Business Operations
    Provita Eurotech Ltd 220688192 MANUFACTURE, PACK, LABEL, ANALYSIS, API MANUFACTURE
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